A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections

NCT ID: NCT00965848

Last Updated: 2013-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-07-31

Brief Summary

The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).

Detailed Description

This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study consists of 4 visits: Visit 1 (Baseline), Visit 2 (End-of-Treatment [EOT], up to Day 14), Visit 3 (Phone visit, Test-of-Cure [TOC], up to Day 14 after EOT) and Visit 4 (Phone visit, Day 90). Participants will receive 500 milligram (mg) of doripenem as intravenous infusion (directly into the vein) every 8 hours for at least 3 days after clinical response and extended up to 14 days. Efficacy will primarily be evaluated by determination of clinical response. Participants' safety will be monitored throughout the study.

Conditions

Infection; Cross Infection; Bacterial Infections; Pneumonia, Ventilator-Associated; Intra-abdominal Infections; Urinary Tract Infections

Keywords

Pneumonia, Ventilator-Associated; Intra-abdominal Infections; Urinary tract Infections; Doripenem; Doribax

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nosocomial Pneumonia

Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.

Group Type: EXPERIMENTAL

Doripenem

Intervention Type: DRUG

Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.

Complicated Intra-Abdominal Infections

Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.

Group Type: EXPERIMENTAL

Doripenem

Intervention Type: DRUG

Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.

Complicated Urinary Tract Infections

Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.

Group Type: EXPERIMENTAL

Doripenem

Intervention Type: DRUG

Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.

Interventions

Doripenem

Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.

Intervention Type: DRUG

Other Intervention Names

Doribax

Eligibility Criteria

Inclusion Criteria

• Male or female participants with 18 years old age and above
• Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
• Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
• Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
• Signed informed consent

Exclusion Criteria

• Pregnant or lactating female participants
• History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
• Hypersensitivity to doripenem and/or excipients
• Previous use of carbapenems within 7 days of study entry
• Participants in terminal stage of malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.,Thailand

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Ltd.,Thailand Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.,Thailand

Locations

Bangkok, , Thailand

Chiang Mai, , Thailand

Chiang Rai, , Thailand

Chon Buri, , Thailand

Khon Kaen, , Thailand

Nakhon Ratchasima, , Thailand

Nakornnayok, , Thailand

Pathum Thani, , Thailand

Countries

Thailand

Other Identifiers

DORIBAC4003

Identifier Type: -

Identifier Source: secondary_id

CR015766

Identifier Type: -

Identifier Source: org_study_id